Severe Bacterial Infection
Conditions
Keywords
Pentaglobin® use, severe bacterial infection
Brief summary
International registry on the use of Pentaglobin® in patients with severe bacterial infections; multicentric, international registry, non-interventional trial
Detailed description
Aim of the Pentaglobin® registry of adult critically ill patients with severe infections is primarily to assess the effects of IVIgAM on the aforementioned outcome parameters and its side effects under real-life conditions based on a prospective, high-quality data documentation * Age ≥ 18 years * Diagnosis of severe bacterial infection * Pentaglobin® use * signed informed consent for data collection Exclusion criteria None Primary endpoints * Comparison APACHE II and SAPS II predicted mortality vs. observed hospital mortality and * Difference in SOFA scores, baseline vs. posttreatment (24 h after last application) assessment Secondary endpoints * In-hospital mortality total and in subgroups according to baseline IgM serum levels (\< 80 mg/dL vs. ≥ 80 mg/dL) and baseline CRP (\< 70 mg/L vs. ≥ 70 mg/L) * Change in MOF score from the day before treatment start till 24 h after last application of Pentaglobin * Course of laboratory markers (concentration-difference): CRP, procalcitonin, IL-6, IgM, IgA, IgG before treatment start till 24 h after last application as far as available in the centers * Duration of ICU stay (days) * Duration of hospital stay (days) * Time from onset of severe bacterial infection to start of treatment
Interventions
None listed
Sponsors
Jena University Hospital
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥ 18 years * Diagnosis of severe bacterial infection * Pentaglobin® use * signed informed consent for data collection -
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| APACHE II and SAPS II predicted mortality vs. observed hospital mortality and | up to 6 months | predicted mortality vs. observed hospital mortality |
| difference in SOFA scores, baseline vs. posttreatment (24 hours after last application) assessment | baseline and 24 hours after last application of Pentaglobin | change in SOFA scores, baseline vs. posttreatment (24 hours after last application) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Course of laboratory markers (concentration-difference): CRP, procalcitonin, IL-6, IgM, IgA, IgG before treatment start till 24 h after last application as far as available in the centers | period between baseline and 24 hours after last application of Pentaglobin | IL-6, IgM, IgA, IgG before treatment start till 24 hours after last application as far as available in the centers |
| Duration of ICU stay (days) | up to 6 months | Duration of ICU stay (days) |
| In-hospital mortality total and in subgroups according to baseline IgM serum levels and baseline CRP | up to 6 months | In-hospital mortality total and in subgroups according to baseline IgM serum levels and baseline CRP |
| Time from onset of severe bacterial infection to start of treatment | up to 14 days | Time from onset of severe bacterial infection to start of treatment |
| Duration of hospital stay (days) | up to one year | Duration of hospital stay (days) |
| Change in MOF score from the day before treatment start till 24 hours after last application of Pentaglobin | period between baseline and 24 hours after last application of Pentaglobin | Change in MOF score from the day before treatment start till 24 hours after last application of Pentaglobin |
Countries
Brazil, Colombia, Germany, Turkey (Türkiye)
Outcome results
None listed